This study has been transitioned to CTIS with ID 2023-505835-11-00 check the CTIS register for the current data. PrimaryTo demonstrate the superiority of galcanezumab versus placebo in the prevention of migraine in an adolescent population (12 to 17…
ID
Source
Brief title
Condition
- Headaches
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The overall mean reduction from baseline in the number of monthly migraine
headache days during the 3*month double-blind treatment phase
Secondary outcome
* The proportion of patients with reduction from baseline >=50% in monthly
migraine headache days during the 3-month double-blind treatment phase
* The proportion of patients with reduction from baseline >=75% in monthly
migraine headache days during the 3-month double-blind treatment
phase
* Monthly: The initial month at which statistical separation in mean change
from baseline in the number of monthly migraine headache days is
demonstrated and maintained at all subsequent months through Month 3
* Weekly (if onset occurred at Month 1): The initial week at which statistical
separation in the number of migraine headache days is demonstrated and
maintained at all subsequent weeks (Weeks 1-4) within Month 1
* Daily (if onset occurred at Week 1): The initial day at which statistical
separation in the proportion of patients with a migraine headache day is
demonstrated and maintained at all subsequent days (Day 1-7) in Week 1
* The overall mean change from baseline in the number of monthly migraine
headache days with nausea and/or vomiting during the 3-month double-blind
treatment phase
* The overall mean change from baseline in the number of monthly migraine
headache days with photophobia and phonophobia during the 3-
month double-blind treatment phase
Background summary
In this study, galcanezumab is being researched. This study drug is not
registered in the Netherlands for chronic migraine in adolescents The product
is approved for the prevention of migraine in adults. It is known that it is
safe and it works for preventing migraine in adults, but it is unknown if the
study drug is safe and works for chronic migraine in adolescents.
Study objective
This study has been transitioned to CTIS with ID 2023-505835-11-00 check the CTIS register for the current data.
Primary
To demonstrate the superiority of galcanezumab versus placebo in the prevention
of migraine in an adolescent population (12 to 17 year-olds) with chronic
migraine
Secondary
* To compare galcanezumab with placebo with respect to 50% response rate
* To compare galcanezumab with placebo with respect to 75% response rate
Time to Onset:
* To compare galcanezumab with placebo with respect to:
o the month of onset of effect
o the week of onset of effect within Month 1
o the day of onset of effect within Week 1
Other Secondary
* To compare galcanezumab with placebo with respect to change in nausea and/or
vomiting symptoms associated with migraine headache.
* To compare galcanezumab with placebo with respect to change in phonophobia
and photophobia symptoms associated with migraine headache
Study design
Study CGAT is a multicenter, randomized, double-blind, parallel group,
placebo-controlled trial with 5 study periods in adolescent patients 12 to 17
years of age who meet ICHD-3 criteria for a diagnosis of chronic migraine as
confirmed during a 1-month prospective baseline period.
Intervention
Sites will administer subcutaneous injections of galcanezumab or placebo at 3
clinic visits during the double-blind treatment phase and administer
galcanezumab at 9 clinic visits during the open-label treatment phase, SP IV
(Section 2). The injection may be given in the abdomen, thigh, upper arm or
buttocks. Site staff may administer comfort measures (such as topical
anesthetic cream, cold compress, or ice pack) to the injection site prior to or
after the injection at their clinical discretion or as needed. Use of
distraction devices during the injection are also
acceptable.
Based on these pediatric dose regimens, the lighter patients (15 to 45 kg)
compared with heavier patients (>45 kg) will receive 1 fewer injection and 50%
of the total volume at Visit 3, and 50% less volume at Visits 5, 6, and 8 to 15.
See Protocol page 37 and 38, Table 7.1 and Section 7.1.1 for additional details
Study burden and risks
Interim analysis of the ongoing pharmacokinetic (PK) addendum to Study CGAS (n
= 25, 21 weighing at least 30 kg and 4 patients weighing less than 30 kg) in
which pediatric patients received at least 1 subcutaneous injection with 120 mg
galcanezumab (1 mL) indicated no
reatment-related SAEs and no discontinuations due to adverse reactions. Most
of the AEs of all causality were mild to moderate in severity. All AEs
considered to be related to study drug dosing were mild to moderate in
severity, and all but one event had resolved. There were no trends of higher AE
risk in patients with longer galcanezumab exposure or lower body weight. Vital
signs, safety laboratory tests, and electrocardiogram (ECG) findings were not
clinically significant.
Given the above safety profile and the need of treatment for children and
adolescents with migraine it is supported to evaluate the use galcanezumab in
pediatric population,
Island House, Eastgate Business Park, Little Island na
Cork Co.
NL
Island House, Eastgate Business Park, Little Island na
Cork Co.
NL
Listed location countries
Age
Inclusion criteria
Have a diagnosis of chronic migraine as defined by the IHS ICHD-3
guidelines (1.3 according to ICHD-3 [2018]), that is, a headache
occurring on 15 or more days per month for at least the last 3 months,
which has the features of migraine headache on at least 8 days per
month.
Exclusion criteria
• Participants who are taking, or are expected to take, therapeutic
antibodies during the course of the study (adalimumab, infliximab,
trastuzumab, bevacizumab, etc.). Prior use of therapeutic antibodies,
other than antibodies to calcitonin gene-related peptide (CGRP) or its
receptor, is allowed if that use was more than 12 months prior to
baseline.
• Known hypersensitivity to monoclonal antibodies or
other therapeutic proteins, or to galcanezumab or its excipients.
• Current use or prior exposure to galcanezumab, another CGRP
antibody, or CGRP receptor antibody, including those who have previously
completed or withdrawn from this study or any other study
investigating a CGRP antibody. Patients must also not have prior oral
CGRP antagonist use within 30 days prior to Visit 2.
• History of IHS ICHD-3 diagnosis of new daily persistent headache,
cluster headache or migraine subtypes including hemiplegic (sporadic or
familial) migraine and migraine with brainstem aura (previously basilartype
migraine).
• History of significant head or neck injury within 6 months prior to
screening; or traumatic head injury at any time that is associated with
significant change in the quality or frequency of their headaches,
including new onset of migraine following traumatic head injury.
• Participants with a known history of intracranial tumors or
developmental malformations including Chiari malformations.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2023-505835-11-00 |
| EudraCT | EUCTR2018-004622-28-NL |
| ClinicalTrials.gov | NCT04616326 |
| CCMO | NL80664.056.22 |