Brief description of trial (Data source: BASEC)
Der Zweck der Studie liegt darin herauszufinden, ob das Arzneimittel AMG 334 unbedenklich ist und gegen Migränekopfschmerzen hilft.
Bei dieser Studie wird Patienten mit episodischer Migräne über den Zeitraum von etwa 12 Wochen jeden Monat entweder AMG 334 oder ein wirkstofffreies Scheinmedikament (Placebo) unter die Haut gespritzt. Danach besteht die Möglichkeit, im zweiten Studienteil über den Zeitraum von etwa 52 Wochen monatlich AMG 334 zu erhalten. Es werden regelmässig medizinische Untersuchungen (einschliesslich Blutentnahmen) durchgeführt. Zudem protokollieren die Teilnehmenden ihren Gesundheitszustand auf einem Handheld-Gerät, das einem iPhone ähnelt.
Am Ende der Studie werden die Teilnehmenden wieder die normale medizinische Versorgung erhalten wie vor der Studie.
Health conditions investigated(Data source: BASEC)
Episodische Migräne (Migräne mit weniger als 15 Migränetagen pro Monat)
Health conditions
(Data source: WHO)
Migraine Prevention
MedDRA version: 20.0Level: PTClassification code 10027599Term: MigraineSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
AMG 334 ist ein Medikament, das noch nicht für die Behandlung von Menschen mit Migräne zugelassen worden ist. Bisher wurden in klinischen Studien ungefähr 2‘000 Menschen mit diesem Medikament behandelt. Zurzeit laufen drei Schlüsselstudien zur Beurteilung der Sicherheit und Wirksamkeit von AMG 334 in Patientengruppen mit episodischer oder chronischer Migräne.
Interventions
(Data source: WHO)
Product Code: AMG334
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Not applicable
CAS Number: 1582205-90-0
Current Sponsor code: AMG334
Other descriptive name: AMG334
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 70-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Criteria for participation in trial
(Data source: BASEC)
- Migräne (mit oder ohne Aura) seit mindestens 12 Monaten.
- 4 bis 14 Migränetage pro Monat (durchschnittlich in den vergangenen drei Monaten).
- 2 bis 4 vorherige prophylaktische Therapien haben bereits versagt.
Exclusion criteria
(Data source: BASEC)
- Patient(in) war beim ersten Auftreten der Migräne älter als 50 Jahre.
- Patient(in) kann Migränekopfschmerzen nicht von anderen Kopfschmerzen unterscheiden.
- Vorgeschichte von Cluster-Kopfschmerz (periodisch stark gehäufte Kopfschmerzen mit teils langen beschwerdefreien Zeiten) oder hemiplegischer Migräne (Migräne mit Halbseitenlähmung).
Inclusion/Exclusion Criteria
(Data source: WHO)
Inclusion criteria:
- Documented history of migraine (with or without aura) for = 12 months prior to screening according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3)
- 4 to 14 days per month of migraine symptoms (based on ICHD-3 criteria) on average across the 3 months prior to screening based on retrospective reporting
- <15 days per month of headache symptoms (ie migraine and non-migraine)
- Failed 2 to 4 prior migraine prophylaxis treatments out of the following: Propranolol/metoprolol, topiramate, flunarizine, valproate/divalproex, amitriptyline, venlafaxine, lisinopril, candesartan, locally approved products (e.g. oxeterone or pizotifen)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 210
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
Exclusion criteria:
- Older than 50 years of age at migraine onset
- Unable to differentiate migraine from other headaches
- History of cluster headache or hemiplegic migraine headache
- Failed more than 4 prior migraine prophylaxis treatments [as specified in protocol]
- Use of a prophylactic migraine medication within 5 half-lives, or a device or procedure within one month prior to the start of the baseline phase or during the baseline phase
- Prior Botulinum toxin A treatment in the head/neck region (including cosmetic use or other licensed indications for Botox ®) within 4 months
prior to start of or during the baseline phase
- Use of the following for any indication in the 1 month prior to the start of the baseline phase or during the baseline phase:
o ergotamines or triptanes =10 days/month, or
o simple analgesics (NSAIDs, acetaminophen, paracetamol) =15 days/month, or
o opioid- or butalbital-containing analgesics =4 days/month
-
Further information on trial
Date trial registered
Nov 8, 2016
Incorporation of the first participant
Mar 16, 2017
Recruitment status
Not Recruiting
Academic title
(Data source: WHO)
A 12-week double-blind, randomized, multicenter study comparing the efficacy and safety of once monthly subcutaneous 140 mg AMG 334 against placebo in adult episodic migraine patients who have failed 2-4 prophylactic treatments (LIBERTY)
Type of trial
(Data source: WHO)
Interventional clinical trial of medicinal product
Design of the trial
(Data source: WHO)
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
Phase
(Data source: WHO)
Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): noTherapeutic confirmatory - (Phase III): yesTherapeutic use (Phase IV): no
Primary end point
(Data source: WHO)
Main Objective: To evaluate the effect of AMG 334 compared to placebo on the proportion of patients with at least 50% reduction from baseline in monthly migraine days;Secondary Objective: To evaluate the effect of AMG 334 compared to placebo on the change from baseline of monthly migraine days
To evaluate the effect of AMG 334 compared to placebo on the impact on everyday activities” domain as measured by the MPFID
To evaluate the effect of AMG 334 compared to placebo on the physical impairment” domain as measured by the Migraine Physical Function Impact Diary (MPFID)
To evaluate the effect of AMG 334 compared to placebo on change from baseline in monthly acute migraine-specific medication treatment days
To evaluate the effect of AMG 334 compared to placebo on the proportion of patients with at least 75% reduction from baseline in monthly migraine days
To evaluate the effect of AMG 334 compared to placebo on the proportion of patients with a 100% reduction from baseline in monthly migraine days
To evaluate the safety, tolerability, and immunogenicity of AMG 334
To evaluate clinical benefit as assessed by the investigator during the PTA Open-Label
Treatment Epoch;Primary end point(s): Achievement of at least a 50% reduction from baseline in monthly migraine days in the last month (month 3) of the double-blind epoch;Timepoint(s) of evaluation of this end point: Month 3
Secundary end point
(Data source: WHO)
Timepoint(s) of evaluation of this end point: For full details, please refer to the schedule of assessments table in the protocol.;Secondary end point(s): Change from baseline on monthly migraine days in the last month of the double-blind epoch
Change from baseline to month 3 of the MPFID impact on everyday activities sub-domain score
Change from baseline to month 3 of the MPFID physical impairment sub-domain score
Change from baseline of monthly acute migraine medication treatment days in the last month of the double-blind epoch
The achievement of at least a 75% reduction from baseline in monthly migraine days in the last month of the double-blind epoch
The achievement of at least a 100% reduction from baseline in monthly migraine days in the last month of the double-blind epoch.
Occurrence of cardiovascular events and evaluation of anti-drug antibodies in this patient population
Exploratory Open-Label Epochs: additional data in a subset of patients in the PTA-Open-Label Treatment Epoch (anticipated up to an additional 6 months of data)
Contact information
(Data source: WHO)
Novartis Pharma Services AG
Trial results
(Data source: WHO)
Results summary
A 12-week double-blind, randomized, multicenter study comparing the efficacy and safety of once monthly subcutaneous 140 mg AMG 334 against placebo in adult episodic migraine patients who have failed 2-4 prophylactic treatments (LIBERTY)
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Bad Zurzach, Lausanne, Zurich
Countries
(Data source: WHO)
Australia, Austria, Belgium, Czech Republic, Czechia, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Dr. Michael E. Arzt
+41 79 561 93 35
michael.arzt@novartis.com
Contact for general information
(Data source: WHO)
Clinical Trial Information Desk
Lichtstrasse 35
Novartis Pharma Services AG
+4461324 1111
clinicaltrial.enquiries@novartis.com
Contact for scientific information
(Data source: WHO)
Clinical Trial Information Desk
Lichtstrasse 35
Novartis Pharma Services AG
+4461324 1111
clinicaltrial.enquiries@novartis.com
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Kantonale
Ethikkommission Zürich
Date of authorisation by the ethics committee
02.05.2017
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2016-01326
Secondary ID (Data source: WHO)
CAMG334A2301
NT 03096834
2016-002211-18-CZ
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