Cluster HeadacheLUMIAVFcNCT06540651
Efficacy of Light Therapy in Treatment of Chronic Cluster Headache
A study testing use of Luminettes ® with active light emission and use of Luminettes ® with a light emission presumed to have no therapeutic effect in people with Cluster Headache, run by Assistance Publique Hopitaux De Marseille at 2 sites in France.
Trial summary
Cluster headache is a primary headache. The chronic form of the disease is often difficult to treat. It is now considered a chronobiological disease. This chronobiological character is based on clinical, biological and radiological arguments. This study focuses on the use of light therapy in cluster headache. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cluster Headache
- What is being tested?
- use of Luminettes ® with active light emission and use of Luminettes ® with a light emission presumed to have no therapeutic effect
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesFrance
- Study dates
- 6 Feb 2025to 5 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, of 18 years years old or more;
- Diagnosis of chronic cluster headache according to ICHD-3 criteria;
- Number of seizures during baseline equal to at least 24;
- Stability of prophylactic treatment for at least 1 month and commitment not to change it for the duration of the study;
- Patient affiliated to the French social security system.
- Patient who understands and speaks French correctly;
- Patient who has given free and informed written consent.
Who cannot join
- Contraindication to the use of light therapy: use of a photosensitizing treatment;
- Ophthalmological history: cataract, macular degeneration, glaucoma, retinitis pigmentosa;
- Patients who work at night;
- Other neurological, psychiatric or developmental pathologies considered incompatible with the study;
- Background treatment of cluster headache with melatonin;
- Persons protected by articles L1121-5, L1121-6 and L1121-8 of the French Public Health Code (pregnant or breast-feeding women, persons deprived of their liberty by judicial decision, socially vulnerable persons, adults incapable or unable to express their consent).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Hopital La Timone
Marseille, 13005
Anne Donnet, +33491384345, anne.donnet@ap-hm.fr
- Not yet recruiting
Hôpital de Cimiez
Nice, 06000
Michel LANTERI-MINET
About this study
Official title: Proof-of-concept Study on the Efficacy of Light Therapy in the Prophylactic Treatment of Chronic Cluster Headache
Cluster headache is a primary headache. The chronic form of the disease is often difficult to treat. It is now considered a chronobiological disease. This chronobiological character is based on clinical, biological and radiological arguments.
This study focuses on the use of light therapy in cluster headache. Light therapy has already been used in the treatment of other chronobiological diseases, such as seasonal depression, but also recently in the therapy of other primary headaches (such as migraine). Its aim is to re-adjust chronobiological rhythms, and it therefore seems worth testing in the chronic form of cluster headache.
Light therapy is delivered to the patient using a consumer electronics device.The main objective is to evaluate the prophylactic efficacy of light therapy in patients with chronic cluster headache.
- Conditions
- Cluster Headache
- Being tested
- use of Luminettes ® with active light emission, use of Luminettes ® with a light emission presumed to have no therapeutic effect
- Medical subject headings
- Cluster Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of Luminettes ® with active light emissionOther
Spectrum of 400 < X < 750 nm assumed active
use of Luminettes ® with a light emission presumed to have no therapeutic effectOther
Modification of spectrum parameters for wavelengths covered, with light emission in a spectrum of 560 < X < 650 nm assumed to have no therapeutic effect
| Study group | Role | What they receive |
|---|---|---|
| Experimental group (group 1) | Experimental | Luminette® with active light emission in the 400 < X < 750 nm spectrum Receives: Other: use of Luminettes ® with active light emission |
| Control group (group 2) | Placebo comparator | Luminette ® with modified spectral parameters for wavelengths covered, with light emission in a spectrum of 560 < X < 650 nm assumed to have no therapeutic effect (placebo effect) Receives: Other: use of Luminettes ® with a light emission presumed to have no therapeutic effect |
What is being measured
The primary outcome is the main question the study is designed to answer.
The median weekly number of cluster headache attacks
The difference in the median weekly number of cluster headache attacks between the month prior to randomization and the month of the double-blind period, between the two arms.
Measured: At day 28
Secondary outcomes (4)
Incidence and nature of adverse reactions
Headache, eye fatigue, dry eyes, nausea
Measured: Daily
Intensity of cluster headache
mild, moderate, severe, very severe
Measured: Daily
Use of acute treatments
sumatriptan and oxygen therapy
Measured: Daily
Patient's Global Impression of Change (PGIC) score
From better outcome, score 1 (Highly improved) to worse outcome, score 7 (Highly aggravated)
Measured: At day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start6 Feb 2025
- Primary completion5 Feb 2027 (estimated)
- Study completion5 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cluster HeadacheStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540651
- Sponsor's protocol ID
- RCAPHM23_0463
- Other IDs
- 2024-A01453-44
- Acronym
- LUMIAVFc
- Status last verified
- Feb 2025
- First submitted
- 2 Aug 2024
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof-of-concept Study on the Efficacy of Light Therapy in the Prophylactic Treatment of Chronic Cluster Headache
- ClinicalTrials.gov ID
- NCT06540651
- Acronym / sponsor ID
- LUMIAVFc / RCAPHM23_0463
- Conditions
- Cluster Headache
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- 5 Feb 2027 (estimated)
- Study completion
- 5 May 2027 (estimated)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cluster headache is a primary headache. The chronic form of the disease is often difficult to treat. It is now considered a chronobiological disease. This chronobiological character is based on clinical, biological and radiological arguments.
This study focuses on the use of light therapy in cluster headache. Light therapy has already been used in the treatment of other chronobiological diseases, such as seasonal depression, but also recently in the therapy of other primary headaches (such as migraine). Its aim is to re-adjust chronobiological rhythms, and it therefore seems worth testing in the chronic form of cluster headache.
Light therapy is delivered to the patient using a consumer electronics device.The main objective is to evaluate the prophylactic efficacy of light therapy in patients with chronic cluster headache.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group (group 1) | Experimental | Other: use of Luminettes ® with active light emissionLuminette® with active light emission in the 400 < X < 750 nm spectrum |
| Control group (group 2) | Placebo comparator | Other: use of Luminettes ® with a light emission presumed to have no therapeutic effectLuminette ® with modified spectral parameters for wavelengths covered, with light emission in a spectrum of 560 < X < 650 nm assumed to have no therapeutic effect (placebo effect) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, of 18 years years old or more;
- Diagnosis of chronic cluster headache according to ICHD-3 criteria;
- Number of seizures during baseline equal to at least 24;
- Stability of prophylactic treatment for at least 1 month and commitment not to change it for the duration of the study;
- Patient affiliated to the French social security system.
Key exclusion criteria (6 listed)
- Contraindication to the use of light therapy: use of a photosensitizing treatment;
- Ophthalmological history: cataract, macular degeneration, glaucoma, retinitis pigmentosa;
- Patients who work at night;
- Other neurological, psychiatric or developmental pathologies considered incompatible with the study;
- Background treatment of cluster headache with melatonin;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| use of Luminettes ® with active light emissionSpectrum of 400 < X < 750 nm assumed active | Other | Experimental group (group 1) |
| use of Luminettes ® with a light emission presumed to have no therapeutic effectModification of spectrum parameters for wavelengths covered, with light emission in a spectrum of 560 < X < 650 nm assumed to have no therapeutic effect | Other | Control group (group 2) |
Primary outcome
The median weekly number of cluster headache attacks
Time frame: At day 28
The difference in the median weekly number of cluster headache attacks between the month prior to randomization and the month of the double-blind period, between the two arms.
4 secondary outcomes
Incidence and nature of adverse reactions
Time frame: Daily
Intensity of cluster headache
Time frame: Daily
Use of acute treatments
Time frame: Daily
Patient's Global Impression of Change (PGIC) score
Time frame: At day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing use of Luminettes ® with active light emission and use of Luminettes ® with a light emission presumed to have no therapeutic effect in people with Cluster Headache, run by Assistance Publique Hopitaux De Marseille at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne DONNET (+33491384345, anne.donnet@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The median weekly number of cluster headache attacks (time frame: At day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.