Intervention: Minocycline
Trial phase: Phase 1 | Phase 2
ATC code: A01AB23 | D10AF07 | J01AA08 | J01AA20
SMILES: [H][C@@]12Cc3c(N(C)C)ccc(O)c3C(=O)C1=C(O)[C@]1(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]1([H])C2
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Oral administration of minocycline

Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months.
Eligibility criteria:
INCLUSION CRITERIA:
To be eligible, the following inclusion criteria must be met, where applicable.
Participant must be 12 years of age or older.
Participant (or legal guardian) must understand and sign the protocol's informed consent document.
Participant must have evidence of retinitis pigmentosa (RP) as defined by characteristic electroretinogram (ERG) responses and visual fields.
Participant must be able to swallow pills.
Participant must have normal renal function and liver function or have mild abnormalities not above grade 1 as defined by the Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
Participant must agree to minimize exposure to sunlight or artificial ultraviolet (UV) rays and to wear protective clothing, sunglasses and sunscreen [minimum sun protection factor (SPF) 15] if s/he must be out in the sun.
Any female participant of childbearing potential must have a negative pregnancy test at screening and be willing to undergo pregnancy tests throughout the study.

Any female participant of childbearing potential and any male participant able to father children must have (or have a partner who has) had a hysterectomy or vasectomy, be completely abstinent from intercourse or must agree to practice two acceptable methods of contraception throughout the course of the study and for at least one week after investigational product (IP) discontinuation. Acceptable methods of contraception include:

hormonal contraception (i.e., birth control pills, injected hormones, dermal patch or vaginal ring),
intrauterine device,
barrier methods (diaphragm, condom) with spermicide, or
surgical sterilization (hysterectomy or tubal ligation).

EXCLUSION CRITERIA:

A participant is not eligible if any of the following exclusion criteria are present.

Participant is actively receiving study therapy in another investigational study.
Participant is started on (or changed dosage of) topical or systemic carbonic anhydrase inhibitor (CAI) treatment in the 3 months prior to enrollment.
Participant is actively receiving systemic steroids or has received systemic steroids in the 3 months prior to enrollment.
Any female participant of childbearing potential that is pregnant, breast-feeding or planning to become pregnant during the study.
Participant is expected to be unable to comply with study procedures or follow-up visits.
Participant has evidence of an ocular disease other than RP in either eye that may confound the outcome of the study (e.g., diabetic retinopathy with 10 or more hemorrhages or microaneurysms, uveitis, pseudovitelliform macular degeneration, severe myopia).
Participant is on ocular or systemic medications known to be toxic to the lens, retina or optic nerve (e.g., ethambutol, chloroquine, or hydroxychloroquine).
Participant has a condition that would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control) by interfering with the participant s ability to engage in the required protocol evaluation and testing and/or comply with study visits.
Participant has a history of chronic renal failure requiring dialysis or kidney transplant.
Participant has a history of chronic hepatitis or liver failure.
Participant has a history of thyroid cancer.
Participant has an allergy or hypersensitivity to minocycline or any drug in the tetracycline family.
Participant is currently taking a tetracycline medication.
Participant is taking any medication that could adversely interact with minocycline such as methoxyflurane.
Participant has a prior history of idiopathic intracranial hypertension.