GNAO1Phase 2ZINCGNAO1NCT06412653
Prospective Pilot Trial to Address Feasibility and Safety of Oral Zinc in GNAO1 Associated Disorders
A Phase 2 study testing Zinc Acetate Dihydrate in people with GNAO1 and Dystonia, run by Children's University Hospital Cologne, Germany at 1 site in Germany.
Trial summary
The goal of this clinical trial is to investigate feasibility and safety of an oral therapy with zinc in patients affected by Guanine nucleotide-binding protein G(o) subunit alpha (GNAO1) associated disorders. Read more about this study
- Who is it for?
- Ages 6 months to 30 years
- What is being tested?
- Zinc Acetate Dihydrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteGermany
- Study dates
- 2 Aug 2024to 4 Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 6 months to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- GNAO1 associated neurological disorder, documented by either
- Proven pathogenic or likely pathogenic mutation in GNAO1 or
- a variant of unknown significance in GNAO1 and clinical symptoms likely to be consistent with GNAO1 as determined by the investigators and
- at least one of the common symptoms of GNAO1: Movement disorder (Dystonia, Chorea, Ataxia, clonic), central muscular hypotonia, epilepsy, global developmental delay
- Age: 6 month - 30 years
- GMFM ≤ 75
Show all 11Show fewer
- written informed consent prior to any trial-related procedure (according to age and status of psycho-intellectual development)
- of parents or legal guardian
- of parents or legal guardian and patient
- of the patient
- stable on following concomitant treatments for at least 3 months prior to trial inclusion: anti-seizure drugs (ASD); baclofen, Deep brain stimulation settings
Who cannot join
- Treatment of Zinc in the last 4 months before inclusion
- known other genetic variants that are known to cause symptoms like observed in GNAO1-related disorders, additional to the proven GNAO1 mutation
- implantation of Deep brain stimulation planned during the duration of the trial, i.e. in the six months after inclusion
- start of intrathecal baclofen therapy planned during the duration of the trial, i.e. in the six months after inclusion
- Known allergy/hypersensitivity to the scheduled trial drug
- Concomitant participation in other clinical drugs with investigational drugs or with competing interventions
- sexually active patients who are not willing to use/ not using a highly effective contraception method with a pearl-index < 1. Sexually active patients, unless surgically sterile, must be using a highly effective contraception method (including oral, transdermal, injectable or implanted contraceptives, intrauterine device (IUD), using a condom of the sexual partner or sterile sexual partner) and must agree to continue using such precautions during the whole study period.
- Pregnant women and nursing mothers
Trial locations and contacts
1 site in 1 country.
Germany1 site
Children's Hospital, University Hospital Cologne, University of Cologne
Cologne, 50937
About this study
Official title: Prospective Pilot Trial to Address the Feasibility and Safety of Treatment With Oral Zinc in GNAO1 Associated Disorders
The goal of this clinical trial is to investigate feasibility and safety of an oral therapy with zinc in patients affected by Guanine nucleotide-binding protein G(o) subunit alpha (GNAO1) associated disorders.
The main questions it aims to answer are:
Read more
- Is a daily oral therapy with zinc in GNAO1 associated disorders a safe and feasible therapy?
- Are there potential changes in general motor skills, general behaviour and well being, day/night rhythm, level of dyskinesia and dystonia, frequency of seizures, quality of life and changes in the microbiome of the patients.
Participants with GNAO1 associated disorders will be given an oral zinc therapy for 6 month and will be assessed in 3 visits and 2 phone calls within this trial.
- Conditions
- GNAO1, Dystonia, Epilepsy, Development Delay, Developmental and Epileptic Encephalopathy 17, Neurodevelopmental Disorder With Involuntary Movements
- Being tested
- Zinc Acetate Dihydrate
- Keywords
- GNAO1
- Medical subject headings
- Dystonia, Epilepsy, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc Acetate DihydrateDrug
Also called WILZIN 25mg, WILZIN 50mg, Wilzin
In this single arm trial, all participants will be receive the trial drug zinc acetate dihydrate orally. The Investigational medicinal product (IMP) will be given one hour after meal in a dosage which is recommended in Wilson Disease and has been given in this condition without observing severe adverse effects. If oral administration is not possible due to the disability level of the patient, the IMP can be mortared and suspended and can then be given as suspension orally or via the Percutaneous endoscopic gastrostomy. The total treatment duration in each patient is 6 months with stable dosage over the duration of the trial. If the therapy shows effects, the parents and participants may continue medication after the end of the trial. If not, they will stop the medication after the last visit at the trial site.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Arm | Experimental | Zinc acetate dihydrate in age-adapted dosage ranging from 50mg to 150mg Zn2+ per day according to the recommended dosage in Wilsons Disease. Receives: Drug: Zinc Acetate Dihydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of daily treatment with oral zinc in GNAO1 as assessed by diary.
The feasibility is measured by the actual days that zinc was taken in the right dosage. If zinc was taken in the scheduled dosage at least on 80% of the days it is assumed to be feasible. Parents/caregivers document the daily intake into a diary.
Measured: From first visit at Inclusion to visit after 6 month
Safety of daily administered zinc in GNAO1 as assessed by regular evaluation of the side effects
To assess side effects: two phone calls are made and in each visit at site potential side effects are assessed.
Measured: From first visit at inclusion until last phone call after 7 month
Safety of daily administered zinc in GNAO1 as assessed by regular blood tests
Serum ferritin and copper detect potential deficiencies, caused by regular zinc administration and therefore reduced uptake. Liver enzymes, alkaline phosphates, lipase and amylase are assessed 3 times, since these parameters can be elevated as side effect.
Measured: Blood analysis at baseline, after 3 and 6 month
Secondary outcomes (11)
Level of motor-skills assessed by Gross-motor function measure
The Gross-motor function measure(GMFM-66) is a standardized test for gross motor function, carried out by a physiotherapist. Minimum value 0, maximum value 100; a higher score is a better outcome.
Measured: Compare measure at baseline to visit after 3 and 6 month
Change in quality of life score assessed by Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD) questionnaire for caregivers
The CPCHILD questionnaire is a validated measure of health-related quality of life for children with severe disabilities and is evaluated 3 times in this trial. Parents/caregivers are asked to fill out the questionnaire. The CPCHILD currently consists of 37 items distributed among six sections representing the following domains:
- Activities of daily living/personal care (nine items)
- Positioning, transferring and mobility (eight items)
- Comfort and emotions (nine items)
- Communication and social interaction (seven items)
- Health (three items)
- Overall quality of life (one item) In Section 7, caregivers rate the importance of each of these items' contribution to their child's quality of life.Scores for each domain and for the total survey are standardized and range from a minimum: 0 (worse) to a maximum 100 (best). A higher score is a better outcome.
Measured: Compare measure at baseline to visit after 3 and 6 month
Level of Dystonia assessed by the Burke-Fahn-Marsden Dystonia Rating scale
The Burke-Fahn-Marsden Dystonia Rating Scale is a universally applied instrument for the quantitative assessment of dystonia in both children and adults. It is divided into movement score and disability score. Movement score minimum value 0, maximum value 120; a higher score is a worse outcome with more dystonia present. Disability score minimum value 0; maximum value 30; a higher score is a worse outcome with more disabilities due to dystonia.
Measured: Compare measure at baseline to visit after 3 and 6 month
Level of dyskinesia assessed by the Abnormal involuntary movement scale (AIMS)
The AIMS is a 12-item clinician-rated scale to assess severity of dyskinesias (specifically, orofacial movements and extremity and truncal movements) and will be assessed 3 times at each visit at site.
The minimum score is 0 and the maximum score is 4 (severe). A higher score is a worse outcome showing higher level of dyskinesia.
Measured: Compare measure at baseline to visit after 3 and 6 month
Level of dyskinesia assessed by a movement log for parents/caregivers
Parents/caregivers are given a diary in which they are asked to document the hours per day which are disturbed by movement disorder and involuntary movements.
Measured: Compare first two weeks of treatment to two weeks before the end of the trial
Changes in sleep assessed by diary for parents/caregivers
Parents/Caregivers are asked to fill out a diary addressing time of sleep per day and sleep disturbances.
Measured: Compare first two weeks of treatment to two weeks before the end of the trial
Changes in general behaviour assessed by diary.
Parents/Caregivers are asked to fill out a diary addressing the general behaviour with two questions.
Measured: Compare answers of diary of first two weeks of treatment to two weeks before the end of the trial
Changes in seizure frequency assessed by seizure log.
Parents/Caregivers are requested to document frequency in a seizure log which is part of the diary
Measured: Compare first two weeks of treatment to two weeks before the end of the trial
Changes in seizure duration assessed by seizure log.
Parents/Caregivers are requested to document duration of seizures in a seizure log which is part of the diary
Measured: Compare first two weeks of treatment to two weeks before the end of the trial
Changes in serum level of zinc assessed by regular blood analysis
Serum controls of zinc are assessed three times to measure the changes in serum levels of zinc before and while zinc administration
Measured: Serum controls at baseline, after 3 and 6 month
Microbiome of stool assessed by regular analysis
Analyze of the microbiome in stool to detect changes under therapy with oral zinc.The stool samples should be collected at home in the three days before visit 2 and 3 in special sample tubes that are handed out to the patient at visit 0. The first stool samples should be collected at visit 0 or on the first three days thereafter.
Measured: Samples compared from baseline to samples collected after 3 and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start2 Aug 2024
- Primary completion4 Aug 2025
- Study completion4 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for GNAO1Studies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective single arm, open-label pilot trial
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's University Hospital Cologne, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- The Clinical Trials Centre Cologne, University of Cologne, University of Geneva, Switzerland
- Responsible party
- Principal investigator, Moritz Thiel, MD, Children's University Hospital Cologne, Germany
- Investigators
- Moritz Thiel, MD, Principal investigator, Children's Hospital, University Hospital Cologne, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412653
- Sponsor's protocol ID
- Uni-Koeln-5275
- Acronym
- ZINCGNAO1
- Status last verified
- Jan 2026
- First submitted
- 29 Feb 2024
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Trial results will be published in a scientific journal and presented at national or international congresses. Publication of the results of the trial as a whole is intended. Anonymized individual patient data (IPD) can be made available on reasonable request to the PI after the results are published.
Publications
Larasati YA, Savitsky M, Koval A, Solis GP, Valnohova J, Katanaev VL. Restoration of the GTPase activity and cellular interactions of Galphao mutants by Zn2+ in GNAO1 encephalopathy models. Sci Adv. 2022 Oct 7;8(40):eabn9350. doi: 10.1126/sciadv.abn9350. Epub 2022 Oct 7.
PubMed 36206333Thiel M, Bamborschke D, Janzarik WG, Assmann B, Zittel S, Patzer S, Auhuber A, Opp J, Matzker E, Bevot A, Seeger J, van Baalen A, Stuve B, Brockmann K, Cirak S, Koy A. Genotype-phenotype correlation and treatment effects in young patients with GNAO1-associated disorders. J Neurol Neurosurg Psychiatry. 2023 Oct;94(10):806-815. doi: 10.1136/jnnp-2022-330261. Epub 2023 May 24.
PubMed 37225406Briere L, Thiel M, Sweetser DA, Koy A, Axeen E. GNAO1-Related Disorder. 2023 Nov 9. In: Adam MP, Bick S, Mirzaa GM, Pagon RA, Wallace SE, Amemiya A, editors. GeneReviews(R) [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2026. Available from http://www.ncbi.nlm.nih.gov/books/NBK597155/
PubMed 37956232Savitsky M, Solis GP, Kryuchkov M, Katanaev VL. Humanization of Drosophila Galphao to Model GNAO1 Paediatric Encephalopathies. Biomedicines. 2020 Oct 6;8(10):395. doi: 10.3390/biomedicines8100395.
PubMed 33036271Thiel M, Martakis K, Duran I, Dafsari HS, Schiller P, Weliwitage J, Hero B, Larasati Y, Koval A, Katanaev VL, Koy A. Safety and feasibility of oral zinc for patients with GNAO1-related disorders (ZINCGNAO1): an open-label, single-arm, single-centre, pilot trial in Germany. EClinicalMedicine. 2026 Jul 23;98:104092. doi: 10.1016/j.eclinm.2026.104092. eCollection 2026 Aug.
PubMed 42542632Larasati YA, Solis GP, Koval A, Korff C, Katanaev VL. A Personalized 14-3-3 Disease-Targeting Workflow Yields Repositioning Drug Candidates. Cells. 2025 Apr 8;14(8):559. doi: 10.3390/cells14080559.
PubMed 40277885
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Pilot Trial to Address the Feasibility and Safety of Treatment With Oral Zinc in GNAO1 Associated Disorders
- ClinicalTrials.gov ID
- NCT06412653
- Acronym / sponsor ID
- ZINCGNAO1 / Uni-Koeln-5275
- Conditions
- GNAO1, Dystonia, Epilepsy, Development Delay, Developmental and Epileptic Encephalopathy 17, Neurodevelopmental Disorder With Involuntary Movements
- Keywords
- GNAO1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Children's University Hospital Cologne, GermanyUniversity, hospital or other
- Collaborators
- The Clinical Trials Centre Cologne, University of Cologne, University of Geneva, Switzerland
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- 4 Aug 2025 (actual)
- Study completion
- 4 Aug 2025 (actual)
- First posted
- 14 May 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.
The goal of this clinical trial is to investigate feasibility and safety of an oral therapy with zinc in patients affected by Guanine nucleotide-binding protein G(o) subunit alpha (GNAO1) associated disorders.
The main questions it aims to answer are:
- Is a daily oral therapy with zinc in GNAO1 associated disorders a safe and feasible therapy?
- Are there potential changes in general motor skills, general behaviour and well being, day/night rhythm, level of dyskinesia and dystonia, frequency of seizures, quality of life and changes in the microbiome of the patients.
Participants with GNAO1 associated disorders will be given an oral zinc therapy for 6 month and will be assessed in 3 visits and 2 phone calls within this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective single arm, open-label pilot trial
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm | Experimental | Drug: Zinc Acetate DihydrateZinc acetate dihydrate in age-adapted dosage ranging from 50mg to 150mg Zn2+ per day according to the recommended dosage in Wilsons Disease. |
Who may qualify
- Ages
- 6 months to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- GNAO1 associated neurological disorder, documented by either
- Age: 6 month - 30 years
- GMFM ≤ 75
- written informed consent prior to any trial-related procedure (according to age and status of psycho-intellectual development)
- stable on following concomitant treatments for at least 3 months prior to trial inclusion: anti-seizure drugs (ASD); baclofen, Deep brain stimulation settings
Key exclusion criteria (8 listed)
- Treatment of Zinc in the last 4 months before inclusion
- known other genetic variants that are known to cause symptoms like observed in GNAO1-related disorders, additional to the proven GNAO1 mutation
- implantation of Deep brain stimulation planned during the duration of the trial, i.e. in the six months after inclusion
- start of intrathecal baclofen therapy planned during the duration of the trial, i.e. in the six months after inclusion
- Known allergy/hypersensitivity to the scheduled trial drug
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 |
|---|---|---|
| Zinc Acetate DihydrateAlso: WILZIN 25mg, WILZIN 50mg, WilzinIn this single arm trial, all participants will be receive the trial drug zinc acetate dihydrate orally. The Investigational medicinal product (IMP) will be given one hour after meal in a dosage which is recommended in Wilson Disease and has been given in this condition without observing severe adverse effects. If oral administration is not possible due to the disability level of the patient, the IMP can be mortared and suspended and can then be given as suspension orally or via the Percutaneous endoscopic gastrostomy. The total treatment duration in each patient is 6 months with stable dosage over the duration of the trial. If the therapy shows effects, the parents and participants may continue medication after the end of the trial. If not, they will stop the medication after the last visit at the trial site. | Drug | Interventional Arm |
Primary outcome
Feasibility of daily treatment with oral zinc in GNAO1 as assessed by diary.
Time frame: From first visit at Inclusion to visit after 6 month
The feasibility is measured by the actual days that zinc was taken in the right dosage. If zinc was taken in the scheduled dosage at least on 80% of the days it is assumed to be feasible. Parents/caregivers document the daily intake into a diary.
Safety of daily administered zinc in GNAO1 as assessed by regular evaluation of the side effects
Time frame: From first visit at inclusion until last phone call after 7 month
To assess side effects: two phone calls are made and in each visit at site potential side effects are assessed.
Safety of daily administered zinc in GNAO1 as assessed by regular blood tests
Time frame: Blood analysis at baseline, after 3 and 6 month
Serum ferritin and copper detect potential deficiencies, caused by regular zinc administration and therefore reduced uptake. Liver enzymes, alkaline phosphates, lipase and amylase are assessed 3 times, since these parameters can be elevated as side effect.
11 secondary outcomes
Level of motor-skills assessed by Gross-motor function measure
Time frame: Compare measure at baseline to visit after 3 and 6 month
Change in quality of life score assessed by Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD) questionnaire for caregivers
Time frame: Compare measure at baseline to visit after 3 and 6 month
Level of Dystonia assessed by the Burke-Fahn-Marsden Dystonia Rating scale
Time frame: Compare measure at baseline to visit after 3 and 6 month
Level of dyskinesia assessed by the Abnormal involuntary movement scale (AIMS)
Time frame: Compare measure at baseline to visit after 3 and 6 month
Level of dyskinesia assessed by a movement log for parents/caregivers
Time frame: Compare first two weeks of treatment to two weeks before the end of the trial
Changes in sleep assessed by diary for parents/caregivers
Time frame: Compare first two weeks of treatment to two weeks before the end of the trial
Changes in general behaviour assessed by diary.
Time frame: Compare answers of diary of first two weeks of treatment to two weeks before the end of the trial
Changes in seizure frequency assessed by seizure log.
Time frame: Compare first two weeks of treatment to two weeks before the end of the trial
Changes in seizure duration assessed by seizure log.
Time frame: Compare first two weeks of treatment to two weeks before the end of the trial
Changes in serum level of zinc assessed by regular blood analysis
Time frame: Serum controls at baseline, after 3 and 6 month
Microbiome of stool assessed by regular analysis
Time frame: Samples compared from baseline to samples collected after 3 and 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Background: PubMed 36206333Larasati YA, Savitsky M, Koval A, Solis GP, Valnohova J, Katanaev VL. Restoration of the GTPase activity and cellular interactions of Galphao mutants by Zn2+ in GNAO1 encephalopathy models. Sci Adv. 2022 Oct 7;8(40):eabn9350. doi: 10.1126/sciadv.abn9350. Epub 2022 Oct 7.
- Background: PubMed 37225406Thiel M, Bamborschke D, Janzarik WG, Assmann B, Zittel S, Patzer S, Auhuber A, Opp J, Matzker E, Bevot A, Seeger J, van Baalen A, Stuve B, Brockmann K, Cirak S, Koy A. Genotype-phenotype correlation and treatment effects in young patients with GNAO1-associated disorders. J Neurol Neurosurg Psychiatry. 2023 Oct;94(10):806-815. doi: 10.1136/jnnp-2022-330261. Epub 2023 May 24.
- Background: PubMed 37956232Briere L, Thiel M, Sweetser DA, Koy A, Axeen E. GNAO1-Related Disorder. 2023 Nov 9. In: Adam MP, Bick S, Mirzaa GM, Pagon RA, Wallace SE, Amemiya A, editors. GeneReviews(R) [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2026. Available from http://www.ncbi.nlm.nih.gov/books/NBK597155/
- Background: PubMed 33036271Savitsky M, Solis GP, Kryuchkov M, Katanaev VL. Humanization of Drosophila Galphao to Model GNAO1 Paediatric Encephalopathies. Biomedicines. 2020 Oct 6;8(10):395. doi: 10.3390/biomedicines8100395.
- Derived from this study: PubMed 42542632Thiel M, Martakis K, Duran I, Dafsari HS, Schiller P, Weliwitage J, Hero B, Larasati Y, Koval A, Katanaev VL, Koy A. Safety and feasibility of oral zinc for patients with GNAO1-related disorders (ZINCGNAO1): an open-label, single-arm, single-centre, pilot trial in Germany. EClinicalMedicine. 2026 Jul 23;98:104092. doi: 10.1016/j.eclinm.2026.104092. eCollection 2026 Aug.
- Derived from this study: PubMed 40277885Larasati YA, Solis GP, Koval A, Korff C, Katanaev VL. A Personalized 14-3-3 Disease-Targeting Workflow Yields Repositioning Drug Candidates. Cells. 2025 Apr 8;14(8):559. doi: 10.3390/cells14080559.
- Individual participant dataSharing planned: No. Trial results will be published in a scientific journal and presented at national or international congresses. Publication of the results of the trial as a whole is intended. Anonymized individual patient data (IPD) can be made available on reasonable request to the PI after the results are published.
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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. This study is not recruiting at the moment.
Moritz Thiel, MD principal investigator
Children's Hospital, University Hospital Cologne, University of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zinc Acetate Dihydrate in people with GNAO1 and Dystonia, run by Children's University Hospital Cologne, Germany at 1 site in Germany.
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 11 inclusion and 8 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: finished, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of daily treatment with oral zinc in GNAO1 as assessed by diary. (time frame: From first visit at Inclusion to visit after 6 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06412653, which also lists 6 linked publications.
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 3 Feb 2026.